Efficient drug development relies on informed decision-making. For toxicologists, having timely access to nonclinical study data while studies are in progress is a game-changer. Imagine the ability to monitor research findings as they develop. This change would allow you to adjust study designs in the moment and provide actionable insights to your team.
However, traditional data access methods can be less than timely and produce output formats that are not suitable for data analysis and visualization. This can delay data review and analysis, leaving toxicologists a step behind. Enter SEND Explorer, a software platform that enables real-time SEND (Standard for Exchange of Nonclinical Data) data analysis. Check out this blog to learn about SEND V3.1.1 updates you should know about.
Here, we explore
- the nonclinical study data lifecycle,
- the limitations of traditional data access, and
- how implementing real-time SEND data analysis and visualization can facilitate safety assessments.
Nonclinical Study Data Lifecycle
To understand the value of reviewing non-clinical study data in real-time, let’s review the typical lifecycle of nonclinical studies and the types of data collected during each phase:
- Pretest Phase – Data collected before dosing starts such as body weights, clinical observations, and lab results to establish a baseline.
- Dosing Phase – In-life data for body weight, clinical observations, food consumption, and drug exposure are collected.
- Recovery Phase – Measurements done in the pretest and/or dosing phase continue for animals in the recovery groups.
- Post-life Phase – Gross pathology, organ weights, and histopathology findings are gathered at the study’s conclusion.
See the figure below that shows the flow and availability of data across all phases of a preclinical study.
Limitations of Traditional Nonclinical Study Data Access Methods
Historically, interim study data has been shared in formats like PDFs and Excel files, which come with significant drawbacks:
- Lack of Visualization – PDFs offer static tables with limited insights or context for interpreting relationships between data points.
- Efficiency Challenges – Raw Excel files may vary in format and structure, often requiring significant manual effort to generate meaningful insights.
- Delayed Integration – Delays in the delivery of interim results and variable legacy data formats hinder the integration of data with results from other studies conducted for a drug program, delaying decision-making.
Advantages of Real-Time SEND Data
What if you could access and analyze nonclinical study data in real-time? That’s exactly what SEND Explorer enables. Here’s how:
- Streamlined Data Exchange – Dynamic and scheduled data exchanges in standardized formats (e.g. SEND) between Contract Research Organizations (CROs) and sponsors improve collaboration.
- Visualization Capabilities – Certara’s SEND Explorer software enables researchers to generate compelling graphs and charts to identify patterns, such as dose-response relationships or species differences.
- Cross-Study Analysis – Interim SEND datasets integrate seamlessly with completed studies, building a holistic nonclinical safety profile for the program.
- Enhanced Safety Assessments – Toxicologists can detect trends, refine study designs, and assess safety margins earlier than traditional methods allow.
SEND Explorer allows nonclinical scientists to perform seamless safety analysis and expedite the assessment of compound safety.
Leveraging Nonclinical Software for Real-Time SEND Data Analysis
Certara’s SEND Explorer is revolutionizing how researchers use SEND data. This platform enables:
- Automated workflows for analyzing interim and finalized study data.
- Seamless data integration from various sources, including CROs, specialty labs, internal studies, and completed/historical studies.
- On-the-fly visualizations like graphs and charts, which facilitate the interpretation and communication of key findings.
- Data analysis and visualization with the same tool used by regulators to minimize unexpected submission queries and delays.
Conclusion: Why you need real-time analysis of nonclinical data
Real-time data analysis is the future of nonclinical safety assessment. The SEND standard provides a clear path toward integrating and interpreting complex animal study data through automated data feeds and standardized data formats. Using Certara’s SEND Explorer, toxicologists can optimize data analysis and visualization activities while delivering more efficient and timely safety assessments.
Want to generate single- and multi-study visualizations for ongoing studies to make data-driven decisions? Read our white paper, The Benefits of Real-time Nonclinical Safety Data Analysis to learn how.
